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NCT04288245 · ClinicalTrials.gov registry record · NA
Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries
A NA study of Spinal Cord Injuries and Upper Extremity Paresis, sponsored by Baylor Research Institute.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04288245: Active NA study of Spinal Cord Injuries and Upper Extremity Paresis, sponsored by Baylor Research Institute.
NCT04288245 is a NA study of Spinal Cord Injuries and Upper Extremity Paresis that is active but no longer recruiting, run by Baylor Research Institute. The registered enrollment target is 20 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04288245, a NA study of Spinal Cord Injuries and Upper Extremity Paresis, is active but no longer recruiting, sponsored by Baylor Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Texas Biomedical Device Center at UT Dallas has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, an early feasibility study and an independent, double-blind, placebo-controlled study in chronic stroke participants indicate that VNS is safe in participants with upper limb deficits, and yields a clinically-significant three-fold increase in neural connections during rehabilitation exercises. Given the track record of safety and potential for VNS to enhance recovery of upper limb motor function in spinal cord injured individuals, the purpose of this double blind randomized placebo controlled optional open-label extension study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with SCI. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial. Participants may undergo additional sessions of training with VNS.
Primary Outcome
Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis.
Conditions Studied
Interventions
- DEVICE Active Vagus Nerve Stimulation
- DEVICE Placebo Vagus Nerve Stimulation
Study Locations (1)
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2026-09 |
| Phase | NA |
What the registry record for NCT04288245 still lists
NCT04288245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 2 interventions - of which Active Vagus Nerve Stimulation is the first listed.
NCT04288245 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04288245 about?
NCT04288245 is a clinical study titled "Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries". Texas Biomedical Device Center at UT Dallas has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory ...
What is the current status of trial NCT04288245?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-02-15. Estimated completion is 2026-09.
What conditions does trial NCT04288245 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Upper Extremity Paresis.
What interventions are being tested in trial NCT04288245?
The interventions under investigation include: Active Vagus Nerve Stimulation (DEVICE), Placebo Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04288245?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04288245 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04288245's enrollment target sits among peer trials
20 126th of 202 higher than 66 of 202 other Spinal Cord Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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